Maternal DepressionTHP-TACTSNCT02644902
Technology Assisted Cascade Training and Supervision of Community Health Workers for Thinking Healthy Programme
A study testing Avatar assisted cascade training and Specialist led training in THP in people with Maternal Depression, run by Human Development Research Foundation, Pakistan.
Trial summary
The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Avatar assisted cascade training and Specialist led training in THP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lady health workers currently working in Swat district
Who cannot join
- Physically unwell, lady health workers on leave
About this study
Official title: Effectiveness of Technology Assisted Cascade Training and Supervision of Community Health Workers in Delivering Thinking Healthy Program for Perinatal Depression in a Post-conflict Area of Pakistan- Protocol of a Randomized Controlled Trial
The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Women living in post-conflict areas are at a higher risk of depression than the general population.The key innovation proposed is the development and evaluation of a technology-assisted cascade training and supervision system to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.
Read the detailed description
The Thinking Healthy Program (THP) is a cognitive behaviour therapy (CBT)-based intervention for maternal depression, delivered by non-specialists.In a recent meta-analysis commissioned by the WHO, THP was shown to have a large effect and has been adopted by the WHO for global dissemination through its mhGAP programme. A major challenge in the scaling up of this evidence-based intervention is the provision of training and supervision at scale, especially in post-conflict areas with weak health systems. The investigators aim to meet this challenge by providing technology based solutions to training and supervision. Building on the organization's previous work in this area, investigators aim to develop Avatar-assisted cascade training and supervision system that includes: (a) a interactive voice response system for phone based assessment to screen depression in the community; (b) a Tablet-based manual , using special characters or avatars allowing standardized training to be delivered without the need for a specialist trainer; and (c) a cascade training model whereby specialists supervise, from distance, the community health worker program supervisors, who in turn, supervise the community health workers (CHW) as part of their normal routine.
The Lady Health Worker (LHW) Programme covers 85% of Pakistan's rural population through 115,000 LHWs . If this study is able to provide a technological solution to the training and supervision of health workers, they have the potential to provide treatment to an estimated 5 million women in rural Pakistan with maternal depression.
Investigators intend conducting the study in District Swat affected by multiple humanitarian crises in recent years. Swat has a population of 1,257,602 persons, 86% of whom live in rural areas with the average household size of 8.8 persons with a low female literacy. The resurgence of the Taliban movement in the Swat Valley of Pakistan since 2004, and the military operations in 2009 and the displacement of residents created a humanitarian crisis in the area. The devastating floods of 2010 put thousands of people out of their homes, and caused destruction to houses, roads, schools and health facilities.The health infrastructure of a post conflict zone like Swat is particularly fragile with the health workers under threat of being attacked, limiting their mobility. Mental health impacts of conflict are often severe and may not be depicted in the national statistics.
- Conditions
- Maternal Depression
- Being tested
- Avatar assisted cascade training, Specialist led training in THP
- Keywords
- Avatar assisted cascade training and supervision, maternal depression, postconflict, THP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar assisted cascade trainingOther
Training of health workers in THP through tablets including avatar characters , and cascaded supervision model.
Specialist led training in THPOther
Training and supervision of lady health workers by specialists as in original THP
| Study group | Role | What they receive |
|---|---|---|
| Technology Arm | Experimental | 5 days training of health workers in THP through avatar assisted cascade training and supervision Receives: Other: Avatar assisted cascade training |
| Specialist Arm | Active comparator | 5 days training and supervision of health workers in THP by specialists Receives: Other: Specialist led training in THP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competency of health workers in THP skills measured using ENact assessment tool
The competency of health workers in the two arms will be measured using ENact assessment tool.
Measured: Immediately after intervention
Secondary outcomes (1)
Cost of intervention
Cost of intervention and comparative arm will be assessed from data collected during the trial and analyzed after 3 months.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Development Research Foundation, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644902
- Sponsor's protocol ID
- GCC-THP-TACTS-2015
- Acronym
- THP-TACTS
- Status last verified
- Feb 2017
- First submitted
- 28 Dec 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zafar S, Sikander S, Hamdani SU, Atif N, Akhtar P, Nazir H, Maselko J, Rahman A. The effectiveness of Technology-assisted Cascade Training and Supervision of community health workers in delivering the Thinking Healthy Program for perinatal depression in a post-conflict area of Pakistan - study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:188. doi: 10.1186/s13063-016-1308-2.
PubMed 27048477
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Technology Assisted Cascade Training and Supervision of Community Health Workers in Delivering Thinking Healthy Program for Perinatal Depression in a Post-conflict Area of Pakistan- Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02644902
- Acronym / sponsor ID
- THP-TACTS / GCC-THP-TACTS-2015
- Conditions
- Maternal Depression
- Keywords
- Avatar assisted cascade training and supervision, maternal depression, postconflict, THP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Human Development Research Foundation, PakistanUniversity, hospital or other
- Collaborators
- Duke University, University of Liverpool
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Women living in post-conflict areas are at a higher risk of depression than the general population.The key innovation proposed is the development and evaluation of a technology-assisted cascade training and supervision system to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.
Detailed description
The Thinking Healthy Program (THP) is a cognitive behaviour therapy (CBT)-based intervention for maternal depression, delivered by non-specialists.In a recent meta-analysis commissioned by the WHO, THP was shown to have a large effect and has been adopted by the WHO for global dissemination through its mhGAP programme. A major challenge in the scaling up of this evidence-based intervention is the provision of training and supervision at scale, especially in post-conflict areas with weak health systems. The investigators aim to meet this challenge by providing technology based solutions to training and supervision. Building on the organization's previous work in this area, investigators aim to develop Avatar-assisted cascade training and supervision system that includes: (a) a interactive voice response system for phone based assessment to screen depression in the community; (b) a Tablet-based manual , using special characters or avatars allowing standardized training to be delivered without the need for a specialist trainer; and (c) a cascade training model whereby specialists supervise, from distance, the community health worker program supervisors, who in turn, supervise the community health workers (CHW) as part of their normal routine.
The Lady Health Worker (LHW) Programme covers 85% of Pakistan's rural population through 115,000 LHWs . If this study is able to provide a technological solution to the training and supervision of health workers, they have the potential to provide treatment to an estimated 5 million women in rural Pakistan with maternal depression.
Investigators intend conducting the study in District Swat affected by multiple humanitarian crises in recent years. Swat has a population of 1,257,602 persons, 86% of whom live in rural areas with the average household size of 8.8 persons with a low female literacy. The resurgence of the Taliban movement in the Swat Valley of Pakistan since 2004, and the military operations in 2009 and the displacement of residents created a humanitarian crisis in the area. The devastating floods of 2010 put thousands of people out of their homes, and caused destruction to houses, roads, schools and health facilities.The health infrastructure of a post conflict zone like Swat is particularly fragile with the health workers under threat of being attacked, limiting their mobility. Mental health impacts of conflict are often severe and may not be depicted in the national statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology Arm | Experimental | Other: Avatar assisted cascade training5 days training of health workers in THP through avatar assisted cascade training and supervision |
| Specialist Arm | Active comparator | Other: Specialist led training in THP5 days training and supervision of health workers in THP by specialists |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lady health workers currently working in Swat district
Key exclusion criteria (1 listed)
- Physically unwell, lady health workers on leave
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar assisted cascade trainingTraining of health workers in THP through tablets including avatar characters , and cascaded supervision model. | Other | Technology Arm |
| Specialist led training in THPTraining and supervision of lady health workers by specialists as in original THP | Other | Specialist Arm |
Primary outcome
Competency of health workers in THP skills measured using ENact assessment tool
Time frame: Immediately after intervention
The competency of health workers in the two arms will be measured using ENact assessment tool.
1 secondary outcome
Cost of intervention
Time frame: 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Derived from this study: PubMed 27048477Zafar S, Sikander S, Hamdani SU, Atif N, Akhtar P, Nazir H, Maselko J, Rahman A. The effectiveness of Technology-assisted Cascade Training and Supervision of community health workers in delivering the Thinking Healthy Program for perinatal depression in a post-conflict area of Pakistan - study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:188. doi: 10.1186/s13063-016-1308-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar assisted cascade training and Specialist led training in THP in people with Maternal Depression, run by Human Development Research Foundation, Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Competency of health workers in THP skills measured using ENact assessment tool (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.